MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Insufficiency (1715); Aortic Regurgitation (1716); Mitral Regurgitation (1964); Neurological Deficit/Dysfunction (1982); Right Ventricular Dysfunction (2054); Confusion/ Disorientation (2553); Thromboembolism (2654); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451); Lactate Dehydrogenase Increased (4567)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient was admitted for elevated powers.Patients international normalized ratio has been therapeutic for over one year.Ramp echo was performed which did not show decompression of the left ventricle with higher speeds.Patients ramp echo showed severe aortic regurgitation which worsened on higher pump speed.Left ventricle did not compress as pump speed was raised.Aortic valve did not open.Computed tomography angiography was done as well with no visualization of clot.

Event Description

It was reported through that the patient underwent pump exchange on (b)(6) 2020, from heartmate ii (b)(6) to heartmate 3 (b)(6).

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient had increasing powers and lactate dehydrogenase.Patient also found to have aortic insufficiency.Patient had a transcatheter aortic valve replacement.Lactate dehydrogenase continued to rise and patient had a neurologic event.Decision was made to transfer patient back to yale and underwent pump exchange.

Manufacturer Narrative

Manufacturer's investigation conclusion: upon evaluation of heartmate ii left ventricular assist system (lvas), serial number (b)(6), the presence of pump thrombosis was confirmed that would have contributed to the report of elevated pump power and lactate dehydrogenase (ldh).Additionally, a direct correlation between the heartmate ii lvas and the report of aortic insufficiency (ai), mild mitral value regurgitation, and a neurological event with confusion and speech changes could not be conclusively established through this evaluation.Worsening heart failure with right ventricular failure and shortness of breath was reportedly caused by the confirmed thrombus and ai.The pump was returned assembled with the driveline severed approximately 3.25¿ from the pump housing, and the distal portion of driveline was returned measuring approximately 34.75¿ with controller connector.The apical sewing ring was not returned.The sealed inflow conduit was severed at the inflow conduit flex section and was returned detached from the pump inlet port.The sealed outflow graft hardware was returned detached from the outflow elbow which was attached to the pump outlet port.The sealed outflow graft bend relief (ogbr) hardware and ogbr collar were returned detached.Evaluation of the sealed inflow and outflow conduits revealed no evidence of laminated or denatured depositions or thrombus formations.Examination of the pump upon disassembly revealed a red, non-adhered deposition of moderate size in the proximal side of the outlet stator.The deposition was loosely seated, tissue-like, and non-laminated.Some denaturation was observed towards the distal end of the deposition, and a few contact marks were observed on the outlet bearing cup.The structure of the non-adhered thrombus formation suggested that it did not originate in the proximal side of the outlet stator; however, its specific origin could not be conclusively determined.The denaturation of the deposition and the contact marks on the outlet bearing cup suggested that the deposition was present during support; however, a specific duration of time for which it was present in the device could not be conclusively determined.Examination of the remaining blood-contacting surfaces revealed no evidence of any additional depositions or thrombus formations.The deposition could have caused increased resistance on the rotor, resulting in the elevations in pump power captured in the submitted log files.In addition, through occlusion of the blood path, the deposition would have contributed to the report of elevated ldh.Electrical continuity testing of the returned portion of the driveline did not reveal any discontinuities or shorts.The pump underwent cleaning, reassembly, and functional testing under load conditions using a mock circulatory loop.The retrieved data revealed pump power consumption and pressure values that met manufacturing specification.The pump operated as intended.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit shipped on 05jul2017.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) are currently available.Section 1 ¿introduction¿ of this document lists device thrombosis, hemolysis, neurologic dysfunction, and right heart failure as adverse events that may be associated with the use of heartmate ii lvas.Additionally, section 6 ¿patient care and management¿ (under "pump performance monitoring") outlines indications of pump thrombosis as well as how to respond to such events.This section (under "anticoagulation") also contains information regarding the recommended anticoagulation therapy and inr range.Section 5 "surgical procedures" warns that moderate to severe aortic insufficiency must be corrected at time of device implant.This section of the ifu also warns that patients with mitral or aortic mechanical valves may be at added risk of accumulating thrombi on the valve when supported with left ventricular assist devices.The ifu provides an explanation of each of the pump parameters, including pump power and flow, in sections 1 and 4 "system monitor".Section 1 (under "explanation of parameters") explains that device power is a direct measurement of pump motor voltage and current.Changes in pump speed, flow, or physiological demand can affect pump power.Abrupt changes in power should be evaluated for cause.In addition, device flow and power generally retain a linear relationship at a given speed.However, while power is directly measured by the system controller, the reported flow is estimated, based on power.Since the flow displayed on the system controller is a calculated value, it becomes imprecise at the low and high ends of the linear power-flow relationship.Section 4 cautions that no single parameter is a surrogate for monitoring the clinical status of the patient, and the changes in all parameters should be considered when assessing any clinical situation.Section 6 (under "pump performance monitoring") addresses assessing pump flow and explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that ramp study performed on (b)(6) 2020 demonstrated moderate to severely reduced right ventricular function.A pump clot and aortic insufficiency was determined to be cause of reduced right ventricular function.Pump clot caused a decrease in pump function resulting in right ventricular failure.Patient heart failure was worsening, shortness of breath and high powers noted on pump.A transcatheter aortic valve replacement was done to decrease aortic insufficiency.A neurological event on (b)(6) 2020 caused patient confusion and changes in speech.The neurological event lead to pump exchange which showed thrombus.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10711150
• MDR Text Key: 212303332
• Report Number: 2916596-2020-04986
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6050664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 99